December 9, 2013

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 13-17

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Byron E. Rippke /s/ Byron E. Rippke

Acting Director

Center for Veterinary Biologics

SUBJECT: Summary of Changes for Related Study Protocols

I. PURPOSE

This Notice pertains to all licensees, permittees, and applicants submitting study 

protocols for review by the Center for Veterinary Biologics, Policy, Evaluation, and 

Licensing (CVB-PEL) staff, per Veterinary Services Memorandum (VSM) 800.200, 

Appendix Section 2. The Notice serves to inform submitters on how they can help 

CVB-PEL staff expedite review of study protocols that are similar to previously 

reviewed protocols, by including a list of changes among such protocols. In some 

circumstances, the same approach may apply to similar protocols that are submitted 

concurrently.

II. BACKGROUND

CVB-PEL strives to provide priority review of study protocols. It is common for 

firms to submit a protocol that is similar to a previously reviewed protocol. For 

example, a firm may conduct a duration of immunity (DOI) study that is nearly 

identical in most respects to a short-term efficacy study except for the interval 

between vaccination and challenge. It would be to the firm’s advantage for the DOI 

protocol to include a list of changes in the study design from the short-term efficacy 

protocol, so that CVB-PEL can expedite its review. Often, however, such a list of 

changes or differences is not provided, resulting in increased time for CVB-PEL 

review. Other examples include vaccination-challenge studies for reference 

qualification or non-interference that resemble an earlier short-term efficacy protocol.

VSM 800.200, Appendix Section 2.3.2, recommends that protocols include 

“background information justifying the proposed study, placing it in the context of 

the product’s development, and supporting an understanding of its objective. 

Include a summary of all similar studies previously initiated with the current product 

or related products and a description of other relevant information.” A list of 

changes from a previously reviewed protocol fits within such a summary.

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary 

Biologics

1920 Dayton Avenue

PO Box 844

Ames, IA 50010

(515) 337-6100
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 13-17

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III. ACTION

Protocols may include a summary of changes from another previously reviewed protocol, if 

the two protocols are very similar. Doing so is likely to expedite CVB-PEL review of the 

protocol. The referenced protocol should be clearly identified, preferably with the CVB Mail 

Log number, the firm’s protocol number or identifier (if any), and the date of the CVB 

response letter. In some circumstances, the same approach may apply to similar protocols 

that are submitted concurrently.

IV. IMPLEMENTATION/ APPLICABILITY

This Notice pertains to all study protocols submitted per VSM 800.200, Appendix Section 2.

This policy will be effective immediately from the date of this Notice.

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